Agilis is presenting this year on March 27 at the 2019 HFES Health Care Symposium
2019 Human Factors and Ergonomics in Health Care Symposium
Agilis is presenting this year at the 2019 Human Factors and Ergonomics in Health Care Symposium held March 24 to March 27 and located in Chicago, IL. This year the HFES will be hosting seven workshops and five different tracks for attendees to participate in. Of the various tracks Agilis will be hosting a program in the Medical and Drug-Delivery Devices Track. This track focuses on the application of human factors/user experience to the design and evaluation of medical devices and combination products. Agilis will be presenting on March 27 between 8:30am to 10:00am on Regulatory Imperatives. Below is the overview of the Agilis presentation.
No Human Factors Validation Needed: How Comparative and Threshold Analyses Can Be Successful Alternatives to Validation Testing
FDA expects sponsors of medical devices and products that have the potential for serious harm to submit premarket evidence of safe and effective use and to show that risks to users are minimized as much as practicable. Human factors validation testing is intended to achieve these goals. An alternative approach in some cases is to conduct a threshold analysis. At a basic level, threshold analyses examine the differences in use-related risks between a new combination product and existing comparator product(s) (i.e., defined as products on the market with similar intended users, user interface elements, and user-device interactions). Working under the assumption that FDA-approved comparators are both safe and effective for users, the results from a threshold analysis can provide evidence of safe and effective use by showing that the new or updated product presents no more use-related risk than existing products on the market. When presented in a convincing way (i.e., the sponsor shows that a new product poses no more risk than a FDA-approved comparator product), threshold analyses have been accepted by FDA in lieu of presenting HF validation testing data. This presentation will provide industry leaders with insight into how threshold analysis strategies may be utilized and how FDA may respond to the submission, including real-world, recent case studies.